MAPS helps scientists design, fund, and obtain regulatory approval for studies of the safety and effectiveness of a number of controlled substances. MAPS works closely with government regulatory authorities worldwide such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) to ensure that all of its sponsored research protocols conform to ethical and procedural guidelines for clinical drug research. Included in MAPS’ research efforts are MDMA (Ecstasy) for the treatment of posttraumatic stress disorder (PTSD), LSD and psilocybin for the treatment of anxiety, cluster headaches, and depression associated with end-of-life issues, ibogaine for the treatment of opiateaddiction, and alternative delivery systems for medical marijuana such as vaporizers and water pipes. MAPS officials say the organization's ultimate goal is to establish a network of clinics where these and other treatments can be provided together with other therapies under the guidance of licensed physicians and therapists.[1]

In addition to sponsoring scientific research, MAPS organizes continuing medical education (CME) conferences, sponsors and gives lectures and seminars on the state of psychedelic and medical marijuana research, participates in community events such as music festivals and Burning Man, and publishes a quarterly bulletin with updates about its ongoing research efforts, legal struggles, and educational initiatives. MAPS has also published books dealing with the history and culture of psychedelic medicine and psychedelic therapy.[2]

The psychoactive properties of LSD were discovered in 1943 by Swiss chemist Albert Hofmann when he accidentally ingested a small dose through the skin while studying the compound. Controlled research on human subjects began soon after and Hofmann's colleague Werner Stoll published his findings about the basic effects of LSD on human subjects in 1947.[3]

After the earliest European and American research efforts investigated whether LSD could reliably induce psychotic disorders, some began to evaluate the potential for LSD to assist in traditional Freudian psychotherapy in the 1950s. Studies into the effects of LSD on human creativity and spirituality were also conducted during this period.

The next major development in the history of psychedelic research was the rediscovery of psilocybin by Western society due to the appearance of an article in a 1957 issue of Life magazine written by R. Gordon Wasson detailing his experiences ingesting psilocybin mushrooms in a shamanic ceremony in Mexico.[4] European studies into the use of psilocybin as a psychotherapeutic agent (Duche; Delay et al.) were published as early as 1961. An article by Pichot about the basic effects of psilocybin on 137 normal and unhealthy subjects appeared in the medical journal Lancet in the same year.[5]

In the early 1960s, Harvard University was the seat of two experiments involving psilocybin. The first of these was the Concord Prison Experiment which began in 1961 under the supervision of principal researchers Timothy Leary and Richard Alpert. The purpose of the experiment was to determine if psilocybin-assisted psychotherapeutic techniques could permanently reverse the criminal and anti-social tendencies of 32 state prisoners nearing parole and prevent them from being incarcerated again. Leary's team combined the administration of synthetic psilocybin in guided sessions with a variety of tests and support sessions during and after release.[citation needed]

The next Harvard experiment with crucial implications for the development of psychedelic research was Walter Pahnke'sGood Friday Experiment of 1962. Pahnke set out to determine if psilocybin could be used to facilitate “mystical” experiences and if these experiences could cause permanent and beneficial personality transformation. In order to do so, he recruited 20 Protestant divinity students, 10 of whom would take synthetic psilocybin and 10 of whom would take a placebo. The experiment took place in a basement chapel in which the audio from a Good Friday service conducted in the main chapel upstairs was broadcast. Throughout the short history of LSD research, people unaffiliated or loosely affiliated with the scientific establishment distributed supplies of LSD outside of laboratory settings. Soon the lines between legitimate research and personal experimentation began to blur for some, and as early as 1962 fellow faculty members at Harvard openly criticized Leary and Alpert for abandoning scientific principles and experimenting with LSD outside official research settings. A few months later the university would dismiss both professors for violating university regulations by providing LSD to undergraduates. The controversy at Harvard coincided with greatly increased FDA restrictions on the procurement of LSD for scientific research; although some research did continue, most studies underway before the new FDA restrictions did not. After restricting its manufacture and distribution in 1965, the US government fully criminalized LSD in 1968, after which the European nations which hosted psychedelic research followed suit.[6]

In the United States, legal psychedelic research was reduced to only one program – the studies conducted at the Spring Grove Center in Baltimore which primarily focused on end of life therapy and continued through to 1974. The study, which eventually came to be headed by Pahnke and Grof, resulted in the treatment of over 100 terminal patients, including 31 in a controlled LSD psychotherapy study.[7]

Throughout the 1980s, MDMA was administered in psychiatric and counseling settings, but recreational use also became increasingly widespread. MDMA research was mostly halted in 1985 by the United States government's initiation of proceedings to ensure temporary classification of the compound as a Schedule I drug (a classification made permanent in 1988). As psychedelics gained increasing recognition as potential psychotherapuetic agents, so too were they recognized within popular culture for their recreational use.[citation needed]

Anticipating that the Drug Enforcement Administration (DEA) would move to criminalize MDMA in light of the drug's increasing popularity in recreational use, Rick Doblin, Alise Agar and Debby Harlow organized a non-profit group called Earth Metabolic Design Laboratories (EMDL) to advocate for the potential the therapeutic use of MDMA. By 1984 the DEA had announced its intention to designate MDMA as a Schedule I substance, a categorization that would greatly restrict and regulate the drug's availability, as well as indicate that it held no accepted medical use and a high abuse potential.[8]

EMDL organized supporters to petition the DEA for a scheduling hearing regarding MDMA. Dr. George Greer, Dr. Lester Grinspoon, Professor James Bakalar, and Professor Thomas Roberts contributed to the argument that MDMA belonged in Schedule III, a category that would more readily enable future research and permit the continuation of its use in psychotherapy. Despite such efforts, the DEA pursued emergency scheduling in 1985, citing an imminent risk to public health.[citation needed]

As MDMA was now deemed illegal, held in the same category as such substances as heroin, the only way for it to be employed in scientific inquiry would be through the lengthy and expensive FDA approval process. Holding the belief that MDMA had the unique potential both to aid psychotherapy and eventually to become a prescription medicine, Rick Doblin sought to gain incorporation for MAPS as a 501(c)(3) non-profit research and educational organization. The founding of MAPS was a primary step toward the future envisioning of what Doblin has called a "nonprofit psychedelic-pharmaceutical company."[9] Chartered in 1986, MAPS has since contributed over 12 million dollars towards the scientific study of psychedelics and marijuana in therapeutic applications.[10][11]

Since 1986, MAPS has distributed over 12 million dollars to fund research and education. These include:

Erowid and MAPS have been collaborating on two large reference database projects since 2001. Erowid has been providing expertise and work developing and coordinating construction of an online MDMA Reference library and MAPS begun working on doing a similar project with the Albert Hofmann Foundation's LSD and Psilocybin Library.[12]

Designed a study to examine vaporized or smoked marijuana in the treatment of war related PTSD in veterans, which will evaluate efficacy and safety of multiple strains of herbal marijuana. The study has received FDA approval. MAPS is pursuing the purchase of appropriate strains from the US federal government.[13]

Sponsored efforts by Prof. Lyle Craker, Medicinal Plant Program, UMass Amherst Department of Plant and Soil Sciences, to obtain a license from the Drug Enforcement Administration for a marijuana production facility.[14][15]

Sponsored analytical research into the effects of the marijuana vaporizer, leading to the first human study of marijuana vaporizers conducted by Dr. Donald Abrams of the University of California, San Francisco.[16]

Funded the successful efforts of Dr. Donald Abrams to obtain approval for the first human study in 15 years into the therapeutic use of marijuana, along with a $1 million grant from the National Institute on Drug Abuse.[13]

Obtained Orphan Drug designation from the FDA for smoked marijuana in the treatment of AIDS Wasting Syndrome.[13]

Supported long-term follow-up studies of pioneering research with LSD and psilocybin originally conducted in the 1950s and 1960s.[17]

Sponsoring research by Dr. Evgeny Krupitsky into ketamine-assisted psychotherapy as a potential treatment for heroin addiction and alcoholism.[18]

Sponsoring programs and services at festivals, community events, churches, and schools that provide psychedelic harm reduction and education.[2]

MAPS is a nonprofit 501(c)(3) research and educational organization, funded by donations from individuals and foundations.[20] Donations to MAPS can be restricted to fund a specific project, or be unrestricted.[21] MAPS also receives revenue from conferences and events, such as the Psychedelic Science conference, as well as from the sale of books, merchandise, and art.[22] With a policy of transparency in financial matters, MAPS publishes a detailed annual financial report.[23]

MAPS has a primary focus in researching the effectiveness of using 3,4-methylenedioxymethamphetamine (MDMA) to assist psychotherapy in the treatment of Post-Traumatic Stress Disorder (PTSD). MAPS is the only organisation in the world funding clinical trials of MDMA-assisted psychotherapy, as it is of little interest to commercial pharmaceutical companies. Ultimately, MAPS seeks to achieve FDA approval for the use of MDMA as a prescription medicine.[24]

MAPS completed a US Pilot Study in September 2008 that investigated the effectiveness of MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD), which took place in Charleston, South Carolina.[24] The study sought to determine whether MDMA-assisted psychotherapy would be effective in reducing the symptoms of PTSD in 20 subjects identified with treatment-resistant PTSD resulting from sexual abuse, war, violent crime, and other traumas.[25]

MAPS is conducting a phase 2 pilot study to assess the effectiveness of MDMA-assisted psychotherapy in the treatment of PTSD among veterans of war. The study is taking place in Charleston, SC and is conducting experimental treatment with 16 veterans, both male and female, suffering war-related PTSD. The study will follow a randomized triple-blind protocol and test three different experimental doses.

Outside of the US, MAPS is pursuing the implementation of MDMA/PTSD studies in Canada, Israel, Jordan, and Switzerland. The Canadian study has full approval from an Institutional Review Board (IRB) and from Health Canada, and is waiting to obtain an import permit to import MDMA into Canada. The Israel Study is awaiting approval from the Israeli Institutional Review Board as well as the Ministry of Health before it can proceed with enrolment. An Israeli Defense Force official has indicated a willingness to refer war affected soldiers suffering from PTSD, thus greatly enabling recruitment for the study. The Jordan Study is in development with limited approval from the IRB. A protocol amendment is to be submitted in the near future. MAPS is seeking to enrol both Jordanian nationals as well as Iraqi refugees living in Jordan who are suffering from PTSD. The Switzerland study has received full approval from SwissMedic and has been submitted and accepted by the FDA in the form of an Investigational New Drug application. The study is in progress and nearing completion as MAPS is collecting long-term follow-up data following the experimental treatment of all 12 subjects. The study represents in part MAPS' clinical plan to develop MDMA as a prescription medication with both FDA and European Medicines Agency (EMEA) approval.[24]

MAPS has developed a training protocol that will allow therapists to take part as subjects in a Phase 1 study on the psychological effects of MDMA-assisted psychotherapy on healthy volunteers. MAPS would thus administer one MDMA-assisted psychotherapy session to the therapists in an effort to offer them training as well as evaluate the effects of MDMA. The study has received approval to proceed by both the US FDA and the IRB. Mithoefer, the primary clinical investigator in this study, has received his Schedule 1 license from the DEA, enabling him to administer MDMA within this study.[24]

It is well evidenced that psychoactive mushrooms and a number of other plants containing psychoactive compounds have been valued for millennia by many indigenous tribes across the globe for their spiritual & therapeutic uses.[26]

An explosion of recreational use during the 1960s gained LSD and Psilocybin a great deal of notoriety and ultimately led to their categorization as Schedule I illicit drugs in 1970.[17]

MAPS is committed to exploring the potential use of LSD and psilocybin-assisted psychotherapy in the treatment of patients suffering with the deep anxiety associated with life-threatening illness. Developing new research protocols to meet modern drug development standards, MAPS’ pilot LSD and psilocybin studies will be used to guide development of future treatment methodologies.[17]

MAPS is conducting a study on LSD-assisted psychotherapy in the treatment of anxiety secondary to life-threatening illness. The study is taking place in Solothurn, Switzerland, and is the first study in 35 years to investigate the therapeutic use of LSD in human subjects. The study's primary focus is to assess the safety and effectiveness of conducting LSD-assisted psychotherapy with a population of individuals who are experiencing anxiety associated with life-threatening illness. The study has received approval from the BAG (the equivalent of the DEA in Switzerland), the Ethics Committee (the Swiss IRB), and SwissMedic. Enrolment began in April 2008 and is now complete.[17]

MAPS has also developed a protocol to study the effectiveness of psilocybin-assisted psychotherapy in treating anxiety related to the experience of having a life-threatening illness such as advanced stage cancer. This study is to be conducted in the US under the principal investigation of Sameet Kumar, Ph.D.[17]

The National Institute on Drug Abuse (NIDA) holds a monopoly on the supply of marijuana grown for research in the United States, as they fund the only laboratory licensed to grow it. Since NIDA is solely interested in researching the negative aspects of marijuana use and abuse, studies to explore its potential medical benefit are impossible within the US.

MAPS is the only organization working to demonstrate the safety and efficacy of botanical marijuana as a prescription medicine to the satisfaction of the FDA. For nearly ten years, MAPS has been involved in lengthy and ongoing legal battles with the DEA to end NIDA’s monopoly on research grade marijuana.[13]

Alternatively, MAPS has received full approval from the FDA to study the effectiveness of marijuana, both smoked and vaporized, in the treatment of individuals experiencing war related PTSD. This marks the first time the FDA has approved an outpatient marijuana study.[28]

The MAPS Bulletin (called the MAPS Newsletter before 1995) is the organization's official publication. It provides summaries of psychedelic research conducted under the auspices of the organization and other worldwide research efforts in addition to discussions of psychedelic culture, personal reflections on psychedelic experiences, and writings from leading figures in the psychedelic research community.[29]

MAPS offers educational resources that actively promote psychedelic harm reduction. Psychedelic harm reduction is an approach to minimize harmful consequences and risks associated with the therapeutic and recreational use of psychedelic drugs. A harm reduction approach is an alternative to drug prohibition laws that criminalize users of psychedelic substances. Inexperienced or overwhelmed users of psychedelics sometimes have challenging emotional experiences that are resolved through law enforcement or medical intervention, which may lead to psychological damage long after the trip is over.[30] A harm reduction approach to using psychedelics often includes attention to set and setting, a trip sitter, or framing in the context of psychedelic therapy.

MAPS has provided psychedelic emergency services at festivals such as Hookahville, Burning Man and the Boom Festival. MAPS’ model of psychedelic emergency services is volunteer staffed, peer based and relies on acute intervention.[30] MAPS also provides training and an educational video, which empowers psychedelic users and their peers with therapeutic techniques for use in assisting others through difficult psychedelic experiences. MAPS’ approach to psychedelic harm reduction encourages a new framework for looking at “bad” trips as opportunities for emotional and spiritual growth.

Additionally, MAPS co-sponsors EcstasyData.org, an online resource that provides laboratory testing of ecstasy tablets for a minimal cost, which allows users to know exactly what they are ingesting and to avoid taking mislabeled or impure substances. MAPS has also formed a partnership with Bluelight, a web forum dedicated to harm reduction.

National Institute on Drug Abuse (NIDA) has a government granted monopoly on the production of medical marijuana for research purposes.[35] In the past, the institute has refused to supply marijuana to researchers who had obtained all other necessary federal permits. Medical marijuana researchers and activists claim that NIDA, which is not supposed to be a regulatory organization, does not have the authority to effectively regulate who does and doesn't get to do research with medical marijuana. Jag Davies of the Multidisciplinary Association for Psychedelic Studies (MAPS) writes in MAPS Bulletin:

Currently, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of research-grade marijuana, but no other Schedule I drug, that can be used in FDA-approved research. NIDA uses its monopoly power to obstruct research that conflicts with its vested interests. MAPS had two of its FDA-approved medical marijuana protocols rejected by NIDA, preventing the studies from taking place. MAPS has also been trying without success for almost four years to purchase 10 grams of marijuana from NIDA for research into the constituents of the vapor from marijuana vaporizers, a non-smoking drug delivery method that has already been used in one FDA-approved human study.

NIDA administers a contract with the University of Mississippi to grow the nation's only legal cannabis crop for medical and research purposes,[37] including the Compassionate Investigational New Drug program. United States federal law registers cannabis as a Schedule I drug. Medical marijuana researchers typically prefer to use high-potency marijuana, but NIDA's National Advisory Council on Drug Abuse has been reluctant to provide cannabis with high THC levels, citing safety concerns:[37]

Most clinical studies have been conducted using cannabis cigarettes with a potency of 2-4% THC. However, it is anticipated that there will be requests for cannabis cigarettes with a higher potency or with other mixes of cannabinoids. For example, NIDA has received a request for cigarettes with an 8% potency. The subcommittee notes that very little is known about the clinical pharmacology of this higher potency. Thus, while NIDA research has provided a large body of literature related to the clinical pharmacology of cannabis, research is still needed to establish the safety of new dosage forms and new formulations. In the most recent rejection of medical marijuana by the Federal Government, the DEA denied Professor Craker, Valerie Corral, and MAPS request to end the federal governments monopoly on medical marijuana production and research.

Major events in recent proceedings are notable, as in the 2007 ruling by Administrative Law Judge Mary Ellen Bittner, wherein she recommended that Craker receive a license to grow marijuana for research and that NIDA dismantle its monopoly. The DEA in response overturned the recommended ruling in January 2009, and later denied Craker's Motion to Reconsider in December 2010. In March 2011, Craker's lawyers submitted their final brief in the case. MAPS is pursuing efforts to have the DEA's final ruling rescinded.[13] A detailed timeline of MAPS' attempts to gain access to research grade marijuana is available on the MAPS website.

^Lattin, Don (2010). The Harvard Psychedelic Club: How Timothy Leary, Ram Dass, Huston Smith, and Andrew Weil Killed the Fifties and Ushered in a New Age for America. Harper Collins. ISBN0-06-165593-7.